Study of the No-touch Saphenous Vein Graft

Multicenter Clinical Trial of Myocardial Revascularization Using I-conduit and No-touch Saphenous Vein Graft

Authors hypothesize that "no-touch" saphenous vein as I graft is superior over conventional "no-touch" saphenous vein as free graft in the incidence of graft patency.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Surgery; Graft Failure; Coronary Artery Stenosis; Cardiac Ischemia
• Intervention / Treatment: Procedure: Сoronary bypass surgery according to the I-graft method; Procedure: Сoronary bypass surgery by the method of free conduit

Detailed Description

A multicenter single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of "no-touch" saphenous vein graft patency using it as the conventional free graft (group C) and I graft (group I) for myocardial revascularization more than 28%. If there is truly difference between groups, then total 106 patients for both groups are required to be 90% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the "no-touch" saphenous vein I graft of 28%. The blinding process is applied to a patient, who is informed about received harvesting method of saphenous vein, but don't know the type of the graft cofiguration. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: conventional free graft (group C) 53 patients and I graft (group I) 53 patients. Randomization is conducted befor operation by using accidental sampling.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitry Khvan, Ph.D.; Phone Number: +79069090505; Email: dmhvan@mail.ru

Study Locations

• Russian Federation
  • Novosibirsk Region
    • Novosibirsk, Novosibirsk Region, Russian Federation, 630055
      • Recruiting
      • NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian
      • Contact: Dmitry A Sirota, MD; Phone Number: +79132012140; Email: sirotad@yandex.ru
      • Contact: Dmitry Khvan; Phone Number: +79069090505; Email: dmhvan@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with coronary artery disease requiring three-vessel myocardial revascularization
• Patient consent to the study

Exclusion Criteria:

• The diameter of the target arteries for conduits of the internal mammary arteries is less than 1 mm
• Hemodynamically significant atherosclerosis of the subclavian arteries in the first segment
• Stenosis of the right coronary artery less than 90%
• Concomitant pathology requiring additional simultaneous surgical correction
• Lack of IMA
• COPD with FEV1 <60%
• BMI >35
• Prior heart surgery
• Oncological diseases with a life expectancy of less than 5 years
• ACS
• CKD stage 4 and higher
• The diameter of the SVG is less than 2 mm or its varicose expansion is more than 6 mm
• CLTI IIb and more
• Atherosclerosis of the brachiocephalic artery more than 50%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "no-touch" saphenous vein as I-graft; Coronary bypass surgery according to the I-graft method. Proximal anastomosis to RIMA.	Procedure: Сoronary bypass surgery according to the I-graft method; Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and the formation of an anastomosis of the stump of the right internal mammary artery and end-to-end saphenous vein graft.
Active Comparator: "no-touch" saphenous vein as conventional free graft; Coronary artery bypass grafting using the free conduit technique. Proximal anastomosis to aorta.	Procedure: Сoronary bypass surgery by the method of free conduit; Revascularization of the right coronary artery basin will be performed using "no-touch" SVG and anastomosis of the saphenous vein graft to aorta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency of "no-touch" saphenous vein graft	Assessment of the patency of coronary shunts	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of angina pectoris	Estimated percentage of participants with symptomatic angina at 6 and 12 months after surgery	6 and 12 months after after surgery
MACE	Estimated percentage of participants with major adverse cardiac events at 6 and 12 months post-surgery	6 and 12 months after after surgery
Complications of the conduit fence site	Estimated percentage of participants with wound complications, development of wound infection, postoperative neurological complications at the sampling site at 6 and 12 months after surgery	6 and 12 months after after surgery
Survival rate	Estimated percentage of participants who died at 6 and 12 months after surgery	6 and 12 months after after surgery

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Principal Investigator: Dmitry Khvan, Ph.D., NMCR named after academician E.N. Meshalkin of the Ministry of Health of rhe Russian

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 22, 2025

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: no-touch saphenous vein graft; CABG
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Coronary Stenosis
• Other Study ID Numbers: Super-SVG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No